Follow us on Twitter

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

We are extremely pleased to see that the Food and Drug Administration (FDA) today announced its plan to issue a proposed rule to revise FDA regulations about prescription drug labeling. When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety.

According to a description on the Office of Management and Budget’s (OMB) website, the revised rule would create parity between brand-name drug manufacturers and generic drug manufacturers with respect to revising drug labeling to provide information about newly discovered risks.

Under current FDA regulations, generic manufacturers cannot update their products’ labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.

Almost two years ago, in August 2011, Public Citizen submitted a citizen petition to the FDA asking it to revise its labeling rules to fill the safety gap. The FDA’s proposal suggests that the agency plans to grant that petition.

The description on OMB’s website also states that the FDA’s new proposal would address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.

Many potential hazards are not discovered until years after drugs have been on the market, as documented in a recent Public Citizen report, yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk.

The proposed rule is a classic example of harm reduction. When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs.

Public Citizen, Inc. and Public Citizen Foundation

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

To become a member of Public Citizen, click here. To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.